Job Title: Clinical Research Associate II (CRA II)
Company: ICON Clinical Research
Location: Bangalore, India
Employment Type: Full-time
Work Mode: Office or Home (Hybrid/Flexible)
Department: Clinical Operations
Experience Required: Minimum 2+ years of experience as a Clinical Research Associate (CRA) with hands-on experience in clinical trial monitoring activities.
Education: Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, Biotechnology, Nursing, or a related scientific field.
Salary Package: ₹8–16 LPA (Estimated as per current market standards for CRA II roles in India; final compensation depends on therapeutic area experience, monitoring expertise, and interview performance.)
Key Responsibilities:
Conduct clinical trial monitoring visits including:
Site Qualification Visits (SQV)
Site Initiation Visits (SIV)
Interim Monitoring Visits (IMV)
Close-Out Visits (COV)
Ensure compliance with:
Clinical trial protocols
ICH-GCP guidelines
Regulatory requirements
Sponsor procedures
Monitor patient safety, data integrity, and study quality.
Review source documents and clinical trial data.
Perform query review and resolution to ensure accurate clinical data.
Collaborate with:
Investigators
Site coordinators
Study teams
Sponsors
Support preparation and review of clinical trial documentation.
Contribute to protocol compliance and successful study execution.
Maintain monitoring reports and follow-up documentation.
Required Skills:
Clinical Research Associate (CRA) Experience
Clinical Trial Monitoring
Site Management
Source Data Verification (SDV)
Source Data Review (SDR)
Clinical Trial Documentation
ICH-GCP Guidelines
Regulatory Compliance
Query Management
Patient Safety Monitoring
Data Integrity Management
Investigator & Site Communication
Risk-Based Monitoring Principles
Microsoft Office Suite
Preferred Therapeutic Area Experience:
Oncology
Cardiology
Endocrinology
Vaccine Studies
Preferred Skills:
Experience managing global clinical trials.
Strong understanding of clinical development processes.
Ability to work independently and manage multiple sites.
Excellent communication and organizational skills.
Strong attention to detail and problem-solving ability.
Travel Requirement: Approximately 60% travel required for site monitoring visits.
Work Location: Bangalore, India
Benefits:
Competitive salary and performance incentives.
Health and wellness programs.
Medical, insurance, and retirement benefits (as applicable).
Learning and development opportunities.
Structured career growth pathways.
Opportunity to work on global clinical trials.
Collaborative environment with international clinical research teams.
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